Theresa Strong Named to FDA Patient Engagement Collaborative

IMG_0301_2FPWR is thrilled to announce that Theresa Strong, our Director of Research Programs (and mom to Daniel, with PWS) has been selected to serve on the Patient Engagement Collaborative (PEC) by the U.S. Food and Drug Administration and the Clinical Trials Transformation InitiativeThe collaborative will share ideas on innovative ways for patients and the FDA to work together in the regulatory decision-making process.

Promoting Effective Patient Input

A critically important role of FPWR and the PWS community is to interact effectively with the FDA to convey the experiences of our PWS community, so that those who are making decisions about new drug approvals have an accurate understanding of the medical needs of individuals with PWS, what symptoms are most important to treat, and what would constitute a meaningful improvement in quality of life for those with PWS. Our community has been have been proactive in conveying the patient experience to FDA through a variety of means, including through the work of the PWS Clinical Trials Consortium, but this is an ongoing process as drugs and devices for PWS are tested.

The ability of the patient advocacy community to collaborate with the FDA on regulatory issues has greatly expanded with the passage of the 21st Century Cures Act. But these new opportunities have also generated many discussions and ideas among stakeholders about how best to do gather and incorporate patient input. The Patient Engagement Collaborative (PEC) was appointed to maximize the effectiveness of this process, increasing meaningful patient engagement in medical product development and other regulatory discussions at the FDA. 

How the Collaborative Will Work

The PEC will meet with the FDA several times a year by teleconference and in person to discuss topics such as improving communication between patients and FDA, new strategies to enhance engagement in FDA’s regulatory process, incorporating patient experience data, and promoting communication and transparency. Theresa will serve a 3-year term on the PEC, which includes 16 members from a diversity of patient organizations, caregivers and patients. This is an exciting opportunity for the PWS community to contribute to discussions and efforts to improve patient engagement, at a time when several new drugs for PWS move forward through clinical trials. The Collaborative will share ideas on innovative ways for patients and the FDA to work together in the regulatory decision-making process. 

The PEC's members are:

  • Dawn Aldrich
  • Ronald Bartek
  • Karen Erickson
  • Jeffrey Goldstein
  • Anne Hall
  • Melissa Hogan
  • Elizabeth Joniak-Grant
  • Nancy Lenfestey
  • Isabelle Lousada
  • Stephanie Monroe
  • Lawrence "Rick" Phillips
  • Philip Posner
  • Lynne Quittell
  • Adrienne Shapiro
  • Theresa Strong
  • Dave White

They were selected from nearly 200 nominations received in response to a Federal Register notice published in December 2017. The selection committee, which included patient advocates and staff from Clinical Trials Transformation Initiative (CTTI) and the FDA, worked to identify representatives with diverse perspectives and experiences who could meaningfully contribute and express the patient voice.

“We are excited to welcome these experts to the PEC and are confident that they will make a significant contribution to advancing patient engagement in research and development,” said Pamela Tenaerts, CTTI's executive director. “This group will play a critical role in ensuring that every step of medical product development accounts for patients’ needs.” The CTTI was co-founded by Duke University and the U.S. Food and Drug Administration and is a public-private partnership working to develop and drive adoption of practices that will increase the quality and efficiency of clinical trials. 

Founded Based On Public Feedback

The PEC was created in December 2017 because of public feedback that the FDA requested on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). One suggestion was to create an outside group to give input on patient engagement across the FDA.

“The FDA is committed to expanding its efforts to engage patients in its regulatory decision-making processes,” said Andrea Furia-Helms, director, Patient Affairs Staff, Office of Medical Products and Tobacco, FDA. “This new diverse group of representatives will help enhance the agency’s understanding of how to best engage across patient communities.”

Learn more about PWS clinical trials here

Visit PWS Clinical Trials Page

Topics: News

Susan Hedstrom


Susan Hedstrom is the Executive Director for the Foundation for Prader-Willi Research. Passionate about finding treatments for PWS, Susan joined FPWR in 2009 shortly after her son, Jayden, was diagnosed with Prader-Willi Syndrome. Rather than accepting PWS as it has been defined, Susan has chosen to work with a team of pro-active and tireless individuals to accelerate PWS research in order to change the future of PWS. Inspired by her first FPWR conference and the team of researchers that were working to find answers for the syndrome, she joined the FPWR team in 2010 and led the development of the One SMALL Step walk program. Under Susan’s leadership, over $15 million has been raised for PWS related research.